2014-03829. Agency Information Collection Activities; Proposed Collection; Public Comment Request

AGENCY:

Office of the Secretary, HHS.

ACTION:

Notice.

SUMMARY:

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for reinstatement of a previously-approved information collection assigned OMB control number 0990-0313, which expired on October 31, 2013. Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

DATES:

Comments on the ICR must be received on or before April 25, 2014.

ADDRESSES:

Submit your comments to [e-mail] or by calling [phone].

FOR FURTHER INFORMATION CONTACT:

Information Collection Clearance staff, [e-mail] or [phone].

SUPPLEMENTARY INFORMATION:

When submitting comments or requesting information, please include the document identifier HHS-OS-21431-60D for reference.

Information Collection Request Title: National Blood Collection and Utilization Survey.

Abstract: The National Blood Collection & Utilization Survey (NBCUS) is a biennial survey of the blood collection and utilization community (industry) to produce reliable and accurate estimates of national and regional collections, utilization, safety, and availability of all blood products, some cellular therapeutic products, as well as information on bacterial testing and human tissue transplantation that are of interest to the transfusion medicine community. The 2013 NBCUS shall be funded by the U.S. Department of Health and Human Services (DHHS) and performed by (contactor, to be determined). In previous years, the NBCUS program was performed under the auspices of the National Blood Data Resource Center (NBDRC), a private subsidiary of AABB (formerly known as the American Association of Blood Banks), with private funding.

The survey includes a core of standard questions on blood collection, processing, and utilization practices to allow for comparison with data from previous surveys; additionally, questions to specifically address emerging and developing issues and technologies in blood collection and utilization are included. Biovigilance remains a key theme for the 2013 survey, as continued from the 2007, 2009, and 2011 iterations. To that end, questions on transfusion transmitted infections, transfusion associated circulatory overload, acute hemolysis, delayed hemolysis, and severe allergic reactions are included in the survey.

Need and Proposed Use of the Information: Under the authority of Section 301 of the Public Health Service Act (42 U.S.C.241), as identified in the 1997 HHS Blood Action Plan, and twice in the Advisory Committee on Blood & Tissue Safety & Availability's (ACBTSA) recommendations to the Secretary, there is a need to provide national policy makers with current supply and demand data.

Likely Respondents: Respondents will include approximately 3,000 institutions that include U.S. blood collection and processing facilities, hospital-based transfusion blood banks, and cord blood banks. Participating institutions will be selected from the American Hospital Association (AHA) annual survey database and AABB member list of blood collection facilities.

Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions, to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.

Total Estimated Annualized Burden—Hours

Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden hours
National Blood Collection and Utilization Survey	3,000	1	1	3,000
Total	3,000	1	1	3,000

OS specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Darius Taylor,

Deputy, Information Collection Clearance Officer.